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Cytora Reports Successful Results of Phase 1/2a Trial of Stem Cell Treatment for Diabetic Foot Ulcers

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Cytora’s proprietary oral mucosa stem cells treatment holds potential to be a game changer in the field of stem cell therapy

YOKNEAM, Israel, April 9, 2025 /PRNewswire/ — Cytora, a clinical stage company developing unique stem cell treatments based on human Oral Mucosa Stem Cells (hOMSCs), reported today successful results of a Phase 1/2a clinical trial for treating chronic hard to heal diabetic foot ulcers (DFUs) with its leading allogeneic off-the-shelf cell therapy product, hOMSC200. The study results show that hOMSC200 is safe and did not elicit any immune response in recipients. In addition, hOMSC200 was shown to be significantly more effective than the standard of care procedure in treating DFUs.

“Cytora’s unique patented technology, based on oral mucosa stem cells, holds a potential to be a game changer in the field of stem cell therapy,” stated Prof. Sandu Pitaru, Co-Founder and CTO of Cytora. “We are at the forefront of cell therapy, leveraging a proprietary unique stem cell population discovered in the human oral mucosa. Notably, the embryonic origin of this population is a primordial tissue of the developing embryonic brain. These unique stem cells retain in the adult’s oral mucosa the properties of neural and other stem cell types, making them effective in targeting chronic multifaceted diseases, such as chronic wounds, and neurodegenerative and autoimmune diseases. Our Phase 1/2a clinical trial has demonstrated that the use of this stem cell population in humans is safe and effective in treating hard to heal diabetic foot ulcers.”

“We are extremely pleased and encouraged by the remarkable results we saw in this Phase 1/2a trial,” said Yona Geffen, PhD, CEO of Cytora. “Diabetic foot ulcers are a common complication of diabetes and are extremely difficult to treat, leading to significant morbidity. We are targeting the DFU patient population that do not respond to available treatment options. This study enrolled 21 subjects with a mean wound duration of over 2 years, and our results clearly show that not only is hOMCS200 safe for use, with no recorded adverse events or immunological response to the injected cells, but it is also highly effective. The results of this trial put us on solid footing for applying for an IND during the second half of 2025 that will enable starting a large-scale Phase 2 trial for treating DFUs during 2026.”

The Phase 1/2a trial was a single center, randomized, partially blinded study, comprising two hOMSC200 dose groups (low and high) and one placebo treated group of DFU patients. The study enrolled 21 patients with a mean wound duration of 27 months. Subjects received a single administration of either a high or low dose of hOMSC200 or a placebo and were followed up for 18 months. All subjects also received standard of wound care treatments. The primary end point was safety, including treatment-related adverse events and immunological rejection reactions towards the injected cells. Secondary end points included partial and complete wound closure rate.

Results show no recorded adverse events, and no humoral or cellular immune response elicited by the injected cells. The proportion of complete wound closure was higher in the hOMSC200-treated patients in comparison to placebo in all populations, with no significant difference between the low and high dose groups. In the intent to treat (ITT) analysis, there was a 53% wound closure rate in the treatment group versus a 33% wound closure rate in the placebo group. In the per protocol group, which included 12 patients who adhered to protocol guidelines, there was a 100% success rate, versus a 20% success rate of wound closure in the placebo control group.

About Human Oral Mucosa Stem cells (hOMSCs)1

Cytora’s patented and transformative stem cell platform is based on the discovery of a novel and unique stem cell population in the oral mucosa termed human Oral Mucosa Stem Cells (hOMSC). hOMSCs are a unique population of stem cells originating from the neural crest. In the oral cavity, they mediate rapid wound healing compared to other tissues, promote full tissue regeneration, without scarring, and their activity is not affected by age. In addition, this remarkable pattern of wound healing is negligibly affected by diabetes, which is notorious for impeding wound healing in other locations of the body, primarily in the foot.

Cytora has shown that hOMSCs are easily propagated without losing their unique stem-cell properties – a tiny biopsy of 4x3x2 mm from a healthy donor generates doses for thousands of treatments. These cells combine a high therapeutic potency with an excellent safety profile, and do not elicit immune rejection when transplanted in allogeneic recipients, thus enabling the production of an “off the shelf” stem cell treatment platform for human use.

About Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) are open sores or wounds that occur in individuals with diabetes, due to poor circulation, neuropathy, and impaired wound healing. They can lead to severe infections, gangrene, and even amputation. Approximately 19% to 34% of individuals with diabetes are expected to develop DFU during their lifetime. Treatments include wound care, infection control, offloading pressure, and improving blood sugar control. Advanced treatments include skin grafts, hyperbaric oxygen therapy, and growth factor therapies. Despite all these treatment options, DFUs remain a significant medical challenge, with a healing rate of only 75%, 17% require amputation. In addition, there is a significant increase in mortality rates among patients with DFUs, surpassing that of diabetes alone. There are approximately 1.2M new DFU patients per year in the US alone, with an average treatment cost of $20,000, and severe cases (resulting in amputations) costing > $40K. The global yearly market is estimated at $7.6 Billion.

About Cytora

Established in 2018, Cytora is a biopharmaceutical company at the forefront of stem cell therapy. Cytora developed a revolutionary technology to produce off-the-shelf (allogeneic) therapeutic doses of human Oral Mucosa Stem Cells to treat challenging diseases, including chronic wounds such as incurable diabetic foot ulcers (DFUs) and degenerative diseases such as Parkinson’s Disease, Multiple System Atrophy (MSA), and Alzheimer’s Disease. The Company successfully completed a Phase 1/2a study for treating DFUs and is currently conducting a Phase 1 study for the treatment of MSA. Cytora’s technology platform is based on the discoveries of Prof. Sandu Pitaru, Faculty of Medicine, School of Dentistry at the Tel Aviv University in Israel, who is also the scientific founder of the Company. For additional information, please visit www.cytorastem.com.

Media contact:

Tsipi Haitovsky
Global Media Liaison
+972-52-598-9892
Tsipihai5@gmail.com

1 Arie I, Pal A, et al., 2024. The Lamina Propria of the Oral Mucosa Harbors a Neural Crest-Like Stem Cell Population Resistant to Hyperglycemia Induced by Diabetes Type II, Medical Research Archives, [online] 12(5). https://doi.org/10.18103/mra.v12i5.5181

 

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Gamehaus Holdings Inc. to Announce Interim Financial Results for the First Nine Months of Fiscal 2025 on May 19, 2025

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May 15, 2025

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SHANGHAI, May 15, 2025 /PRNewswire/ — Gamehaus Holdings Inc. (“Gamehaus” or the “Company”) (Nasdaq: GMHS), a technology-driven mobile game publisher, today announced that it will release its unaudited financial results for the first nine months of fiscal year 2025 ended March 31, 2025, before the U.S. market opens on May 19, 2025.

The management team of Gamehaus will host a conference call at 08:00 A.M. Eastern Time on Monday, May 19, 2025 (08:00 P.M. Beijing/Hong Kong time on the same day) to discuss the financial results. In advance of the conference call, all participants must use the following link to complete the online registration process. Upon registering, each participant will receive access details for this conference including a conference passcode, a unique PIN number (personal access code), dial-in numbers, and an e-mail with detailed instructions to join the conference call.

Participant Online Registration: https://dpregister.com/sreg/10199786/ff24367338

A live and archived webcast of the conference call will be available on the Company’s Investor Relations website at https://ir.gamehaus.com/.

About Gamehaus

Gamehaus Holdings Inc. is a technology-driven mobile game publisher dedicated to nurturing partnerships with small- and medium-sized game developers to amplify their success. “You make successful games. We make games successful” is the company’s mantra, encapsulating its commitment to transforming potential into prosperity through data-driven monetization support and optimizing game publishing solutions. For more information, please visit https://ir.gamehaus.com/.

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, the Company’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that may affect its financial condition, results of operations, business strategy and financial needs. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may”, or other similar expressions in this press release. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s most recent filings with the U.S. Securities and Exchange Commission.

Investor Relations Contact
Gamehaus Holdings Inc.
Investor Relations Team
Email: IR@Gamehaus.com 

The Blueshirt Group
Mr. Jack Wang
Email: Gamehaus@TheBlueshirtGroup.co 

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SOURCE Gamehaus Holdings Inc.

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Bridge to Life Announces Abstract Presentations at The 2025 International Congress of the International Liver Transplantation Society (ILTS) in Singapore, May 28-31, 2025

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May 15, 2025

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Abstracts to highlight hypothermic oxygenated perfusion (HOPE) in liver transplants, including pediatric patients

CHICAGO, May 15, 2025 /PRNewswire/ — Bridge to Life™ Ltd., a leader in organ preservation solutions and perfusion technology, today announced the presentation of nine accepted abstracts, including two late-breakers, at the 2025 International Congress of the International Liver Transplantation Society (ILTS). The conference is scheduled to take place in Singapore, from May 28-31, 2025.

Abstracts to be presented:

Late Breaker: Impact of Machine Perfusion on Ischemia-Reperfusion Injury in Liver Transplantation: A Donor Age-Stratified Analysis, Marco Maria Pascale, Francesco Frongillo, Giorgia Selvaggi, Giuseppe Bianco, Anna Caltabellotta, Erida Nure, Salvatore Agnes, Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy

Late Breaker: Machine Perfusion in Liver Transplantation: A Game Changer for Middle-Volume Centers?, Marco Maria Pascale, Francesco Frongillo, Giorgia Selvaggi, Giuseppe Bianco, Anna Caltabellotta, Erida Nure, Salvatore Agnes, Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy

Use of HOPE Machine Perfusion for Transplantation in Unusual Scenarios – A Case Report, Alba Bueno, Chris Neophytou, George Clarke, Keith Roberts, Khalid Sharif, Rebeca S. Mateos, Hector Vilca-Melendez, Liver Units, Birmingham Children’s Hospital and Queen Elizabeth Hospital, Birmingham, United Kingdom

Hypothermic Oxygenated Perfusion (HOPE) in Pediatric Liver Transplantation: Preliminary Results, Ane Andrés, María Velayos, Javier Serradilla Rodríguez, Alba Sánchez-Galán, José Luis Encinas, Paula Burgos, Iñigo Velasco, Jorge Utanda, Esteban Frauca y Francisco Hernandez-Oliveros, Hospital Universitario La Paz, Madrid, Spain

HOPE for Hepatocellular Carcinoma – Recurrence Analysis in Patients Transplanted with Grafts Submitted to Hypothermic Oxygenated Perfusion, Maria João Amaral; Mariana Duque; Júlio Constantino; Pedro Oliveira; João Simões; Ricardo Martins; António Pinho; Emanuel Furtado; José Guilherme Tralhão; Dulce Diogo, Coimbra University Hospital Centre, Coimbra, Portugal

The Impact of HOPE on Liver Transplantation for ACLF and ALF: A Promising Perspective, Pedro Pinto, Mariana Lobo, Andreia Matos, Pedro Oliveira, Dulce Diogo, José Tralhão; Coimbra University Hospital Centre, Coimbra, Portugal

Results of Implementation of Hypothermic Oxygenated Perfusion (HOPE) for Human Liver Grafts before transplantation in a Tertiary Hospital, Andrea González De Godos, Francisco Javier Tejero Pintor, Martín Bailón Cuadrado, José Carlos Sarmentero Prieto, Pilar Pinto Fuentes, Enrique Asensio Diaz, Paloma Lourdes Rodríguez Vielba, Fernando Labarga Rodríguez, David Pacheco Sánchez, Hospital Universitario Rio Hortega, Valladolid, Spain

HOPE for combined Heart and Liver Transplant, Mireia Caralt, José Andrés Molino, Jesús Quintero, Núria Montferrer, Joan Balcells, Cristina Padrós, Maria Margaret Mercadal, Raul Feline Abella,Ferran Gran, Ernest Hidalgo, Hospital Universitari Vall d’Hebron, Barcelona, Spain

HOPE for the hopeless grafts. Experience from a single center, Mireia Caralt, Laura Vidal, Sandra Torres, José Andrés Molino, Marta Martos, Piero Alberti, Cristina Dopazo, Concepción Gómez, Itxarone Bilbao, Ramon Charco, Ernest Hidalgo, , Hospital Universitari Vall d’Hebron, Barcelona, Spain

In addition to the abstract presentations, Bridge to Life will also be participating in the Hands-On Liver Machine Perfusion Workshop taking place on May 28, 2025.  Separate registration is required: 5th ILTS Hands-on Liver Machine Perfusion Workshop – ILTS Congress 2025. 

Bridge to Life will also be sponsoring a symposium on May 29 at 3:00 pm SST (UTC+8) on “Expanding the Boundaries of Hypothermic Oxygenated Perfusion: Addressing Challenges and Opportunities in the Asia-Pacific Region”.  Speakers include Dr. Sonal Asthana from Aster Hospitals, Dr. Andrea Schlegel from Cleveland Clinic, Ohio and Dr. Rebeca Sanabria Mateos from Queen Elizabeth Hospital, Birmingham.

About Bridge to Life Ltd

Bridge to Life™ Ltd is a market leader in organ preservation solutions, offering premier products such as Belzer UW®, EasiSlush® and the VitaSmart™1 Hypothermic Oxygenated Perfusion System. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading Transplant Centers and Organ Procurement Organizations globally.

1 VitaSmart is CE Marked and available for sale in several markets outside of the United States. VitaSmart is not approved for sale in the US.

Logo – https://mma.prnewswire.com/media/2085277/Bridge_to_Life_Logo.jpg

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Athean Launches with New AI-Powered Sales Platform to Supercharge Prospecting

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May 15, 2025

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SAN FRANCISCO, May 15, 2025 /PRNewswire/ — Athean, a new AI-driven prospecting and engagement platform, launches today to transform how sales teams win deals. Designed to eliminate tool overload and data silos, Athean centralizes the entire sales ecosystem into one intelligent platform. By streamlining workflows and surfacing actionable insights, Athean supercharges prospecting, enabling teams to easily find and meaningfully engage with high-quality prospects.

“Sales reps are inundated with countless tools for prospecting, valuable data is siloed, and time is lost in the endless switching between platforms,” said John Kim, Co-founder and CEO of Athean. “We created Athean to fill a critical void in the sales technology marketplace – a tool thoughtfully designed to help sales teams deploy their skills more effectively and close better deals faster.”

Athean unifies sales data and tools that reps use daily – from CRMs and prospect databases to communication history – into a single platform, and its AI models arm reps with actionable insights into their accounts. Sales engagement, including calls, emails, and sequences, can also be managed directly in Athean. This seamless access to information enables teams to spend less time gathering data and more time connecting with potential customers.

“Athean isn’t just another prospecting tool; it’s a precise, powerful solution created with the explicit goal of helping individuals master the sales process,” said Kim. “Our intelligent platform provides salespeople with detailed, prioritized insights into their prospect pipeline – who to contact, when, and why – so that they can spend their time on what actually moves deals forward: building relationships.”

Key benefits highlighted in early customer experiences include:

Context: With deep insights into prospects, Athean shines a light on the contacts and context sales teams need to connect meaningfully and efficiently with the right prospects, at the right time.Clarity: Simplified, impactful data presentation integrates seamlessly with your existing tech stack which means less tools and fewer tabs, eliminating the distraction and chaos of prospecting to give sales reps clarity and focus.Connection: We estimate Athean can free up as much as two hours every day, allowing reps to do what they do best: building genuine, lasting relationships.

Athean was originally designed at Silicon Valley security company, Verkada, to be used by their 1,000+ person sales team. Athean will operate as an independent venture of Verkada and is now publicly available to sales teams eager to elevate their prospecting efforts. Learn more at Athean.com.

About Athean
Athean is an AI-driven prospecting and engagement platform that unifies customer and prospect data, communications history, and market signals to transform how sales teams win deals. Athean’s AI-powered tools eliminate tab-switching and manual validation, helping sales reps to identify high potential accounts, surface relevant intel and engage with enriched prospect data – arming your team with the contextual knowledge that builds instant credibility. The result: better conversations, more qualified opportunities, and ultimately, more closed revenue. For more information, please visit www.athean.com.

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